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Academic pediatric clinical research: factors associated with study implementation duration.
Delphine Meier-Girard1,2,3,4,5, Annick Tibi6,7, Hendy Abdoul8,9,10
1Université Paris Diderot, Sorbonne Paris Cité, UMR-1123 ECEVE, F-75019, Paris, France. delphine.gd@gmail.com.
BMC Medical Research Methodology
|March 31, 2016
Summary
Pediatric research implementation is often delayed. Interventional studies, especially those involving drug therapy with age-inappropriate formulations or dosages, face significant delays. Anticipating pharmaceutical challenges is key to faster study completion.
Area of Science:
- Clinical Research
- Pediatric Medicine
- Health Services Research
Background:
- Pediatric research faces ethical, methodological, and technical challenges, leading to implementation delays.
- Identifying factors influencing the duration of hospital-based pediatric studies is crucial for improving efficiency.
Purpose of the Study:
- To identify factors associated with the implementation duration of hospital-based pediatric studies.
- To analyze the impact of funding mechanisms, methodological factors, and pharmaceutical aspects on study timelines.
Main Methods:
- Retrospective analysis of 139 hospital-based pediatric studies sponsored by AP-HP (2002-2008).
- Multivariable mixed linear models assessed associations between funding, methodology, and implementation duration.
- Subgroup analysis explored pharmaceutical factors in drug therapy studies.
Main Results:
- Median implementation duration was 17.1 months, increasing over time (2002-2008).
- External and internal funding, and multi-center designs were associated with reduced duration.
- Interventional studies, particularly those involving drug therapy, placebo-controlled designs, and pediatric-only populations, showed increased duration.
Conclusions:
- Interventional pediatric studies, especially drug therapy trials, experience significant implementation delays.
- Challenges with age-appropriate drug/placebo formulation and supply contribute to delays.
- Proactive anticipation of pharmaceutical-related difficulties is essential to avoid implementation delays.
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